Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) has proposed new regulations to standardize labeling requirements for prescription and over-the-counter animal drugs, as well as those for use in animal feeds. These regulations aim to offer consistent information for veterinarians, animal owners, and producers regarding the safe and effective use of these drugs. While the FDA has historically followed certain labeling practices, they have not been formally regulated until now.

The proposed regulations would establish comprehensive requirements for the content and format of labeling, streamlining the preparation and review process for drug sponsors. In addition, the FDA seeks to amend or remove existing regulations for consistency. Public comments on the proposal are welcomed for 90 days, with a deadline of June 10, 2024. If finalized, compliance would be required for future drug applications and staggered for previously approved drugs over six years.

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